{"id":1933,"date":"2024-01-10T16:36:00","date_gmt":"2024-01-10T15:36:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1933"},"modified":"2024-04-10T16:45:14","modified_gmt":"2024-04-10T14:45:14","slug":"47-liecivo-efgartigimod-alfa-vyvgart-na-liecbu-myastenie-gravis","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/47-liecivo-efgartigimod-alfa-vyvgart-na-liecbu-myastenie-gravis\/","title":{"rendered":"47: Lie\u010divo efgartigimod alfa (Vyvgart) na lie\u010dbu myast\u00e9nie gravis"},"content":{"rendered":"
    \n
  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Myast\u00e9nia gravis (MG) je z\u00e1va\u017en\u00e9 nevylie\u010dite\u013en\u00e9 neurologick\u00e9 ochorenie, vznikaj\u00face na autoimunitnom podklade. MG patr\u00ed medzi zriedkav\u00e9 ochorenia. Je vysoko za\u0165a\u017euj\u00faca pre pacientov, preto\u017ee vy\u017eaduje lie\u010dbu kortikosteroidmi a nesteroidn\u00fdmi imunosupres\u00edvami (NSI), ktor\u00e1 so sebou prin\u00e1\u0161a mnoh\u00e9 ne\u017eiaduce \u00fa\u010dinky. Taktie\u017e vystavuje pacientov riziku \u017eivot ohrozuj\u00facej myastenickej kr\u00edzy. Lie\u010dba pod\u013ea najnov\u0161\u00edch medzin\u00e1rodn\u00fdch \u0161tandardov u pacientov s nedostato\u010dne kontrolovanou MG zah\u0155\u0148a aj lie\u010dbu efgartigimodom alfa. <\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Efgartigimod alfa je fragment \u013eudsk\u00e9ho imunoglobul\u00ednu G, ktor\u00fd zvy\u0161uje odb\u00faravanie protil\u00e1tok proti takzvan\u00e9mu acetylchol\u00ednov\u00e9mu receptoru.<\/p>\n\n\n\n

      Vyvgart bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare pre hodnoten\u00fa indik\u00e1ciu v auguste 2022.<\/p>\n\n\n\n

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      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n

        Pod\u013ea vyjadren\u00ed odborn\u00edka pre pacientov nereaguj\u00facich dostato\u010dne na \u0161tandardn\u00fa lie\u010dbu a Intraven\u00f3zny imunoglobul\u00edn v udr\u017eiavacej lie\u010dbe neexistuje moment\u00e1lne \u017eiadna mo\u017enos\u0165 eskal\u00e1cie lie\u010dby. Pova\u017euje za potrebn\u00e9 ma\u0165 na Slovensku kategorizovan\u00e9 alternat\u00edvy lie\u010dby pre tak\u00fdchto pacientov, aby nebolo nutn\u00e9 sa spolieha\u0165 na schv\u00e1lenie v\u00fdnimky zo strany pois\u0165ovne. Vn\u00edma ako etick\u00fa v\u00fdzvu nemo\u017enos\u0165 t\u00fdchto pacientov lie\u010di\u0165 pod\u013ea najnov\u0161\u00edch vedeck\u00fdch poznatkov.<\/p>\n\n\n\n

          \n
        1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

          Dr\u017eite\u013e registr\u00e1cie (Argenx) podal \u017eiados\u0165 o zaradenie lie\u010diva efgartigimod alfa (Vyvgart) na lie\u010dbu myast\u00e9nie gravis.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Vyvgart v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie spl\u00ed tieto dve podmienky: <\/p>\n\n\n\n

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          • uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/li>\n\n\n\n
          • zmen\u00ed indika\u010dn\u00e9 obmedzenie pod\u013ea n\u00e1vrhu NIHO<\/li>\n<\/ul>\n\n\n\n

            V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri uvedenej \u00fahrade spojen\u00fd s vysokou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. Odpor\u00fa\u010dame po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>\n\n\n\n

            Z\u00e1rove\u0148 NIHO odpor\u00fa\u010da zv\u00e1\u017ei\u0165 dopl\u0148uj\u00facu zmenu indika\u010dn\u00e9ho obmedzenia.<\/p>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Vyvgart v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e…<\/p>","protected":false},"author":3,"featured_media":1934,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[126,125],"class_list":["post-1933","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-efgartigimod-alfa","tag-vyvgart"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1933","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1933"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1933\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1934"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1933"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1933"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1933"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}